Observations: Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

Pfizer Consumer Healthcare

Issued: 03/08/2011

Region: Southeast

Inspectors: Jose E. Melendez
Eva Merced

Observations: Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Kenwick, Inc.

Issued: 07/30/2010

Region: Pacific

Inspector: Lakecha Lewis

Observations: Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in the specifications or manufacturing or control procedures.

Electro-Cap International, Inc.

Issued: 04/28/2011

Region: Central

Inspector: Brigitte K. Hofmann

Observations: Your firm has introduced or delivered for introduction into interstate commerce a device that has been significantly changed or modified in materials and chemical composition without submitting a premarket notification to FDA, as required by 21 CFR 807.81(a)(3).

Eastern Cranial Affiliates, LLC

Issued: 04/13/2011

Region: Central

Inspector: James W. Leonette

Observations: Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system with sufficient frequency.

Biolab Company

Issued: 03/01/2011

Region: Southeast

Inspector: Rafael Gonzalez

Observations: Production processes were not developed, conducted, controlled, and monitored to ensure that a device conforms to its specifications.

3CPM Company, Inc.

Issued: 02/25/2011

Region: Central

Inspector: Merideth K. Rose

Observations: Results of validation of the device software were not adequately documented.